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临床试验/NCT03434665
NCT03434665已完成不适用

Transradial Selective Catheterization of the Celiac Artery in Obese Patients: A Pilot Study

Laval University2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2018年2月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
54
试验地点
2
主要终点
Percentage of successful selective angiographies

研究概览

简要总结

BACKGROUND:

  • Obesity, with its associated comorbidities, is set to become a major risk factor for cardiovascular disease in the 21st century. To this day, diet and medical therapy have proven only limited efficacy and bariatric surgery remains the last resort for many severely obese patients who wish to lose weight, modify their cardiovascular risk factors and ultimately modify their long-term prognosis. However, bariatric surgery remains associated with significant procedural morbidity and many patients are not eligible for such a surgery procedure as the risk-benefit ratio of bariatric surgery in severe obese patients with coronary artery disease is not yet well known.
  • Recently, percutaneous left gastric artery embolization has been reported as a promising technique leading to a body weight loss that is equivalent to bariatric surgery.
  • In the context of an endovascular procedure in obese patients, vascular access is a major concern. Transradial access (or radial artery approach) has been consistently associated with significant reductions in access-site related vascular complications and peri-procedural bleeding compared to the standard transfemoral access (or femoral artery approach). This is particularly evident in patients with severe obesity.
  • Visceral arteries most often have an acute angulation with the aorta which makes them more easily cannulated from above (transradial access) compared to below (transfemoral access). Preliminary experience has shown that cannulation of the celiac artery is feasible from transfemoral and transradial access, the latter being associated with shorter procedural time and less contrast agent use. To date, several pilot studies have reported successful percutaneous embolization of the left gastric artery with biodegradable microspheres. This appears to be a promising technique to reduce weight in severely obese patients.
  • Prior to launching a randomized trial, further study is warranted regarding the feasibility and safety aspects of transradial angiography of the celiac artery.

详细描述

RATIONALE:

  • A significant proportion of patients referred to IUCPQ-UL catheterization laboratory are overweight (body mass index >25 kg/m²).
  • Ongoing research and early clinical experience suggest that embolization of the left gastric artery could drastically reduce ghrelin levels and be associated with significant weight loss.
  • In obese patients, catheterization using femoral artery access is associated with higher risks of vascular complications and peri-procedural bleeding compared to a radial artery approach.
  • Given the anatomy (angle) of the celiac artery, selective catheterization of the celiac and left gastric arteries remains challenging, especially in obese patients.
  • Before studying the effects of bariatric embolization, more data regarding the access of the left gastric artery is necessary.

HYPOTHESES:

  • Transradial angiography of the celiac artery/left gastric artery is feasible and safe.
  • Given the angulation of celiac artery, catheterization through a radial approach could be simpler.
  • Selective angiography of the celiac artery and the left gastric artery can be performed in the setting of uncomplicated coronary angiography/percutaneous coronary intervention (PCI).
  • Detailed anatomy of the celiac artery and its branches can be visualized by selective transradial angiography.

OBJECTIVES:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing coronary angiography with a BMI >30 kg/m² will be eligible.

排除标准

  • Kidney disease defined by a glomerular filtration rate less than 60 ml/min/m² according to the Modification of Diet in Renal Disease (MDRD) formula;
  • Previous gastric or bariatric surgery;
  • Emergency coronary procedure.
  • Furthermore, the procedure will be cancelled if one of the following criteria are met during the coronary angiography:
  • Contrast volume >250 ml;
  • Radiation dose >180 Gy.cm² as assessed by the dose area product (DAP).

结局指标

主要结局

Percentage of successful selective angiographies

时间窗: Baseline

The primary end-point will be the percentage of successful selective angiographies of the celiac artery.

次要结局

  • Radiation exposure (dose)(Baseline)
  • Number of catheters(Baseline)
  • Incidence of complications of angiographies(Baseline)
  • Radiation exposure (duration)(Baseline)
  • Contrast volume(Baseline)
  • Procedure duration(Baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Olivier F. Bertrand

MD PhD; Interventional Cardiologist, Quebec Heart-Lung Institute; Associate-Professor, Faculty of Medicine, Laval University

Laval University

研究点 (2)

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